U.S. - Remote - Sample Management Lab Project Manager

Job Responsibilities and Requirements:

The Sample Management Lab PM is part of the Clinical Development Operation (CDO) unit within the Clinical Portfolio Execution (CPE) team; he/she is accountable for ensuring the end-to-end lifecycle of clinical samples from company clinical trials across study planning, study execution and study close-out.
The Sample Management Lab PM establishes company laboratory management strategy, processes and standards, support the selection and oversees central laboratory vendors, ensures compliant and on time delivery within budget across global programs.

The GTSM is a key member of the Study Execution Teams (SETs), an ad-hoc member of other Clinical Development Teams, oversees outsourcing for routine sample testing, and takes preventive/corrective action(s) to address issues/risks associated with sample activities.

He/She is supporting budget management, protocol development, feasibility and start-up activities, providing guidance where required.

The Sample Management Lab PM is also responsible for ensuring that all sample activities are conducted in accord to Good Clinical Practice (GCP) and Good Clinical Laboratory Practices (GCLP). and to all relevant guidelines within the company QA-regulated environment.

• Responsible for project managing all aspects of the end-to-end clinical sample lifecycle across global portfolio of clinical trials, including, but not limited to:

• Sample collection protocols (Study Operational Sample Management Plan),

• Support for the development of lab site manual and to ensure sample kits & ancillary supplies are available on site,

• Sample shipment from clinical/investigator sites/depots to external vendor 300+ sites across 15+ countries),

• Oversight on central testing conduct according to the optimized, validated protocol(s),

• Support for the review of budget for clinical sample testing and logistics,

• Support for finalization of Data Transfer Specification/Data Transfer Agreement (DTS/DTA) for central and specialty labs,

• Lead the lab specific sub working group within the SET,

• Issue/risk identification and resolution; ensure escalation pathway to Snr/GTL and/or Program Director, as needed.

• Responsible for identifying, evaluating and selecting external vendors capable of conducting central lab activities and sample testing to support pivotal global clinical trials. Accountable for oversight of clinical samples vendors and ensuring quality of data is robust and per validated protocols.

• Responsible for managing clinical samples per country regulations and/or informed consent procedures. Capability to oversee and manage complex sample collection and shipping process across global regions (Asia Pacific, Americas (NA and LATAM), Europe, Middle East and Africa).

• Review validation protocols for clinical testing and ensures testing is in compliance with clinical protocol, local regulations and Good Clinical Practice (GCP) and Good Clinical Laboratory Practices (GCLP).

• Establishes and maintains close relationship with manufacturing facilities and External Reference Laboratories.

• Support Research and Clinical Bioanalytics (RCB) and Vaccine Innovation Unit (VIU) serology functions to drive optimization of assays and/or changes to testing procedures as requested by Regulatory Authorities.

• Provision of serology expertise in responding to Regulatory Agency questions regarding serology testing.

• Responsible for ensuring contracts with external testing and sample processing vendors are executed in a timely manner and are cost effective.

Essential Experience:

• As a guide, a minimum of 5+ years’ relevant clinical research (or related) experience within the pharmaceutical industry.
• Experience in overseeing global vendors supporting clinical trials, sample testing and sample logistics and storage.
• Experience with project management software packages.
• Budget forecasting and review.
• Thorough knowledge of ICH, GCP and GCLP guidelines.
• Experience in working in a QA-regulated environment.
• Ability to work independently with low